Senior Product Development Engineer

SUMMARY:

We are looking for an engineer that can conduct development work as part of a major project. Under minimal supervision and guidance, performs analyses to develop design specifications and performance requirements. Provides technical information concerning manufacturing or processing techniques, materials, properties and process (advantages/limitations) engineering planning. Selects techniques to solve problems and make sound design recommendations. Active medical device experience with catheters is a plus.

Essential Duties and Responsibilities (but are not limited to):

• Work with outside consultants, vendors, and the medical community.
• Ensure that the quality system requirements are being met.
• Support design reviews, board meetings, and Physician visits.
• Lead cross-functional teams in the development of new products.
• Manage product development projects (utilizing appropriate project management tools) to meet deliverables for time, quality, performance, and cost, coordinating high level project plans, managing risk, and driving project success.
• Provide management and project sponsors with appropriate, timely, and accurate updates of project status and plans, including monthly reports, gate review records, and resource requirements.
• Communicate effectively with teams and within management structure to facilitate workflow and affect resolution to project barriers and problems.
• Design, development, and prototyping of new devices, components and processes to meet the customer needs, lower costs and improve the quality of the product.
• Design and develop new test methods and equipment.
• Perform, document and report on investigations and testing.
• Author protocols and procedures for the testing, qualification, validation of product and processes.
• Responsible for notifying QA/QC of any observed or reported product quality issues so that appropriate action may be taken.

Education/Experience:

• 5+ years experience in engineering.
• Bachelors Degree or equivalent years of experience.